PLIANT THERAPEUTICS INC
For the period ended Jun 30, 2024. Filed Aug 7, 2024.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2024 · Filed Aug 7, 2024
PLRX$0.81-0.7%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-03-31; filed 2024-05-06.
0001746473-24-000076
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2024-06-30; filed 2024-08-07.
0001746473-24-000145
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 103 previous paragraphs and 115 current paragraphs.
77 unchanged; 17 reworded; 15 added; 5 removed; 4 previous and 6 current paragraphs rearranged.
Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (15)
Current report
•Results from a 12-week Phase 2a PET imaging trial of bexotegrast in IPF showed reduced total lung collagen and improved forced vital capacity (FVC), suggesting potential for reversal of fibrosis. Results from this randomized, double-blind, placebo-controlled trial (NCT05621252) showed that bexotegrast at a once-daily dose of 160 mg was well tolerated over 12 weeks of treatment and demonstrated reduced total lung collagen as measured by positron emission tomography (PET) imaging, improvements in FVC and reduced cough severity across all time points compared to placebo. These results provide further support of bexotegrast’s antifibrotic mechanism of action and suggest the potential for reversal of fibrosis.
Current report
•Enrollment remains on track in BEACON-IPF, a pivotal adaptive Phase 2b/3 trial of bexotegrast in patients with idiopathic pulmonary fibrosis (IPF). The BEACON-IPF Phase 2b trial is a 52-week, multinational, randomized, dose-ranging, double-blind, placebo-controlled trial evaluating bexotegrast at once-daily doses of 160 mg or 320 mg in 360 patients with IPF. Enrollment is expected to be complete in the first quarter of 2025 with data anticipated in mid-2026.
Current report
•INTEGRIS-IPF Phase 2a trial results published in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). Also known as the “Blue Journal”, AJRCCM is a leading peer-reviewed journal published by the American Thoracic Society. The publication Bexotegrast in Patients with Idiopathic Pulmonary Fibrosis: The INTEGRIS-IPF Study reviews the previously reported positive results from the multinational, randomized, double-blind, placebo-controlled INTEGRIS-IPF Phase 2a trial that enrolled 119 patients with IPF.
Current report
•Positive long-term data from the INTEGRIS-PSC 320 mg cohort showed bexotegrast was well tolerated up to 40 weeks of treatment and demonstrated continued improvements across multiple fibrotic and cholestatic endpoints. The 24-week Phase 2a data readout from the 320 mg dose group showed bexotegrast was well tolerated up to 40 weeks of treatment and showed improvement in liver stiffness, statistically significant reduction in alkaline phosphatase (ALP) and evidence of continued improvement in hepatocyte function and bile flow. Pliant recently met with U.S. Food and Drug Administration (FDA), with the Agency expressing support for a 52-week, dose-ranging Phase 2b trial employing non-invasive endpoints. Pliant continues to evaluate the best path forward for this program.
Current report
•PLN-101325 applications beyond muscular dystrophies. PLN-101325 is a monoclonal antibody that acts as an allosteric agonist of integrin α7β1, currently in development for treatment of muscular dystrophies. Based on preclinical data, PLN-101325 may have the potential to treat additional indications in organ systems outside of muscle. The Company is currently generating additional evidence in support of potential expansion of the scope of PLN-101325 prior to initiating a Phase 1 trial.
Current report
•Appointment of Steve Krognes to the Company’s Board of Directors. Mr. Krognes brings over 30 years of financial and corporate strategy experience in leading and guiding life science companies across all stages of development. Most recently, Mr. Krognes served as Chief Financial Officer of Denali Therapeutics.
Current report
General and administrative expenses for the three months ended June 30, 2024 increased $0.4 million, primarily due to a marginal increase in professional service expenses.
Current report
Interest Expense
Current report
Interest expense for the three months ended June 30, 2024 increased $0.5 million due to additional borrowings under the Amended Loan Agreement executed March 11, 2024.
Current report
Comparison of the six months ended June 30, 2024 and 2023 (in thousands)
Current report
Revenue
Current report
Research and development expenses
Current report
General and Administrative Expenses
Current report
Interest expense for the six months ended June 30, 2024 increased $0.7 million due to additional borrowings under the Amended Loan Agreement executed March 11, 2024.
Current report
Comparison of the six months ended June 30, 2024 and 2023
Removed paragraphs (5)
Previous report
•Acceleration of bexotegrast development plan with implementation of BEACON-IPF as a pivotal, adaptive Phase 2b/3 trial in patients with idiopathic pulmonary fibrosis (IPF). The adaptive design implementation, based on acceptance by the European Union (EU) and other global health authorities, is expected to significantly shorten bexotegrast’s late-stage development compared to standalone Phase 2b and Phase 3 trials. As part of the adaptive Phase 2b/3 implementation, the Phase 2b portion of BEACON-IPF was upsized from 267 patients to 360 patients. Enrollment is progressing and we expect to complete enrollment of the upsized Phase 2b study in the first quarter of 2025.
Previous report
•Completion of a 12 week Phase 2a PET imaging trial, measuring the effects of bexotegrast on total lung collagen and forced vital capacity (FVC) in IPF patients. This randomized, double-blind, placebo-controlled trial was conducted at Massachusetts General Hospital. The trial's primary endpoint is the change in total lung collagen in 10 participants with IPF following once-daily treatment with bexotegrast at 160 mg for 12 weeks. Collagen will be evaluated with PET imaging, utilizing a collagen-binding probe. The secondary endpoint is safety and tolerability. Exploratory endpoints include change in FVC, cough severity and fibrosis biomarkers. Conduct of this trial has been completed, with topline data expected in the coming weeks.
Previous report
•Completion of INTEGRIS-PSC Phase 2a trial in patients with primary sclerosing cholangitis (PSC) with data readout expected mid-year. As previously announced, at a once-daily dose of 320 mg, bexotegrast was well tolerated over 12 weeks of treatment with no drug-related severe or serious adverse events. At the 320 mg dose, bexotegrast reduced both Enhanced Liver Fibrosis (ELF) scores and PRO-C3 levels and showed improvements in hepatocyte function and bile flow by contrast MRI imaging relative to placebo at Week 12. The final 24-week data readout from the 320 mg dose group is expected in mid-2024.
Previous report
•Loan facility with Oxford Finance LLC (Oxford), upsized by $50 million to a total of $150 million of available non-dilutive capital. To date, the Company has drawn a total of $30 million from the facility. The remaining funds available under this facility, along with the Company’s March 31, 2024 cash and cash equivalents and short-term investments of $483.9 million are expected to fund Pliant's anticipated operating expenses and capital expenditure requirements through 2026.
Previous report
Our interest expense is derived from a term loan under an Amended and Restated Loan and Security Agreement (the “Oxford Loan Agreement”) with Oxford Finance LLC (the “Lender”), which amended and restated, in its entirety, the Loan and Security Agreement, dated as of May 4, 2022 (as amended, restated, supplemented or otherwise modified prior to the Effective Date, the “Prior Agreement”) with the Lender and which permits us borrow a series of term loans up to an aggregate principal amount of $150.0 million (the “Term Loans”), of which $50.0 million is subject to the Lender’s sole discretion. Borrowings under the Oxford Loan Agreement bear interest at a rate per annum equal to 1-month term Chicago Mercantile Exchange (“CME”) Term Secured Overnight Financing Rate (“SOFR”) plus 5.25%, subject to an agreed upon floor of 8.75%.
Reworded paragraphs (17)
Previous wording
We are a late-stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis and related diseases. Our initial focus is on treating fibrosis by inhibiting integrin-mediated activation of TGF-β. We have applied our deep understanding of fibrosis biology, along with our medicinal chemistry and translational medicine expertise to develop a set of proprietary tools designed to discover and de-risk product candidates quickly and efficiently. Our wholly owned lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that we are developing for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. We are currently conducting a Phase 2b trial in patients with IPF and a Phase 2a trial in patients with PSC. We announced positive data from our Phase 2a INTEGRIS-IPF trial in May 2023. We are currently conducting BEACON-IPF, a 52-week, randomized, double-blind, placebo-controlled Phase 2b trial in patients with IPF. We announced positive interim data from our Phase 2a INTEGRIS-PSC trial in September 2023 and February 2024. We expect to release final data from the INTEGRIS-PSC trial in mid-2024.
Current wording
We are a late-stage biopharmaceutical company focused on discovering and developing novel therapies for the treatment of fibrosis and related diseases. Our initial focus is on treating fibrosis by inhibiting integrin-mediated activation of TGF-β. We have applied our deep understanding of fibrosis biology, along with our medicinal chemistry and translational medicine expertise to develop a set of proprietary tools designed to discover and de-risk product candidates quickly and efficiently. Our wholly owned lead product candidate, bexotegrast (PLN-74809), is an oral, small molecule, dual selective inhibitor of αvß6 and αvß1 integrins that we are developing for the treatment of idiopathic pulmonary fibrosis, or IPF, and primary sclerosing cholangitis, or PSC. We announced positive data from our Phase 2a INTEGRIS-IPF trial in May 2023 and positive long-term data from our Phase 2a INTEGRIS-PSC trial in July 2024. We are currently conducting BEACON-IPF, a 52-week, randomized, double-blind, placebo-controlled adaptive Phase 2b/3 trial in patients with IPF.
Previous wording
In January 2023, we received FDA clearance of investigational new drug application, or IND, for our third clinical program to date, PLN-101095, a dual inhibitor of integrins αvß8 and αvß1 for the treatment of solid tumors that are resistant to immune checkpoint inhibitors. We are currently dosing the third of five dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data could be available as early as late 2024.
Current wording
In January 2023, we received FDA clearance of investigational new drug application, or IND, for our third clinical program to date, PLN-101095, a small molecule, dual selective inhibitor of integrins αvß8 and αvß1 for the treatment of solid tumors that are resistant to immune checkpoint inhibitors. We are currently dosing the third of five dose cohorts in a Phase 1 open label dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data is expected in late 2024 or early 2025.
Previous wording
Our fourth program, PLN-101325, is in development for treatment of muscular dystrophies, including Duchenne muscular dystrophy. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7ß1. In the first quarter of 2024 regulatory clearance was received for the conduct of a first-in-human Phase 1 clinical study of PLN-101325 which is anticipated to be initiated in 2024.
Current wording
Our fourth program, PLN-101325, is in development for treatment of muscular dystrophies, including Duchenne muscular dystrophy. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7ß1. In the first quarter of 2024, we received regulatory clearance for the conduct of a first-in-human Phase 1 clinical study of PLN-101325.
Previous wording
•Phase 1 trial of PLN-101095 in solid tumors is progressing with dosing of the third of five cohorts. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The Company is currently enrolling the third of five cohorts in the Phase 1 open label, dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data could be available as early as late 2024.
Current wording
•Phase 1 trial of PLN-101095 in solid tumors is progressing with dosing of the third of five cohorts. PLN-101095 is an oral, small molecule, dual selective inhibitor of αvβ8 and αvβ1 integrins designed to block TGF-β activation in the tumor microenvironment. The Company is currently enrolling the third of five cohorts in the Phase 1 open label, dose-escalation trial of PLN-101095 as monotherapy and in combination with pembrolizumab in patients with solid tumors that are resistant to immune checkpoint inhibitors. Preliminary data is expected in late 2024 or early 2025.
Previous wording
Since inception, we have had significant operating losses. Our net loss was $47.0 million and $37.5 million for the three months ended March 31, 2024 and 2023, respectively. As of March 31, 2024, we had an accumulated deficit of $546.7 million and cash, cash equivalents, and short-term investments of $483.9 million. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will increase in connection with our ongoing activities, as we:
Current wording
Since inception, we have had significant operating losses. Our net loss was $55.9 million and $41.2 million for the three months ended June 30, 2024 and 2023, respectively. Our net loss for the six months ended June 30, 2024 and 2023 was $102.8 million and $78.7 million, respectively. As of June 30, 2024, we had an accumulated deficit of $602.6 million and cash, cash equivalents, and short-term investments of $438.1 million. We expect to continue to incur net losses for the foreseeable future, and we expect our research and development expenses, general and administrative expenses, and capital expenditures will increase in connection with our ongoing activities, as we:
Previous wording
Following termination of the Novartis Agreement, we are no longer eligible to receive additional milestone or royalty payments under the arrangement; however, we continued to earn research and development services revenues through the effective termination date of April 18, 2023. We recognized nil and $1.3 million in revenues for performing research and development activities associated with PLN-1474 and integrin research targets in the three months ended March 31, 2024 and 2023, respectively.
Current wording
Following termination of the Novartis Agreement, we are no longer eligible to receive additional milestone or royalty payments under the arrangement; however, we continued to earn research and development services revenues through the effective termination date of April 18, 2023. We recognized nil and $0.2 million in revenues for performing research and development activities associated with PLN-1474 and integrin research targets in the three months ended June 30, 2024 and 2023, respectively.
Previous wording
The decrease in revenue of $1.3 million is attributable to the termination of the Novartis Agreement that went into effect in April 2023.
Current wording
The decrease in revenue of $0.2 million is attributable to the termination of the Novartis Agreement that went into effect in April 2023.
Previous wording
Research and development expenses for the three months ended March 31, 2024 increased $7.9 million, primarily due to BEACON-IPF, a Phase 2b study of bexotegrast in patients with IPF, and employee-related expenses, driven by increased headcount. These costs were partially offset by a decrease in preclinical manufacturing costs associated with activities that were substantially complete in 2023.
Current wording
Research and development expenses for the six months ended June 30, 2024 increased $20.5 million, primarily due to BEACON-IPF, a Phase 2b study of bexotegrast in patients with IPF, employee-related expenses driven by increased headcount, and an increase in depreciation of lab equipment and costs of equipment and supplies. These costs were partially offset by a decrease in preclinical manufacturing costs associated with activities that were substantially complete in 2023, and the Phase 2a clinical trial of bexotegrast in patients with primary sclerosing cholangitis (PSC) has reached its close-out stage in the first quarter of 2024.
Previous wording
General and administrative expenses for the three months ended March 31, 2024 increased $1.1 million, primarily attributable to employee-related costs, driven by increased headcount.
Current wording
General and administrative expenses for the six months ended June 30, 2024 increased $1.5 million, primarily attributable to employee-related costs, driven by increased headcount.
Previous wording
Interest and other income (expense), net increased $1.0 million, attributable to higher interest income due to increased yields and an increase in short-term investments due to current year financing activities.
Current wording
Interest and other income (expense), net increased $0.2 million, attributable to higher interest income due to increased yields and an increase in short-term investments due to current year financing activities.
Previous wording
As of March 31, 2024, we had $483.9 million of cash, cash equivalents and short-term investments. Our short-term investments consist of U.S. Treasury securities, U.S. Government agency securities and highly rated, investment-grade corporate debt securities.
Current wording
As of June 30, 2024, we had $438.1 million of cash, cash equivalents and short-term investments. Our short-term investments consist of U.S. Treasury securities, U.S. Government agency securities and highly rated, investment-grade corporate debt securities.
Previous wording
We believe that our existing capital resources, together with the funds available to us under the Amended Loan Agreement, will be sufficient to fund our anticipated operating expenses and capital expenditure requirements for the next 12 months and through 2026. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned.
Current wording
We believe that our existing capital resources, together with the funds available to us under the Amended Loan Agreement, will be sufficient to fund our anticipated operating expenses and capital expenditure requirements for the next 12 months and beyond. We have based these estimates on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Further, our operating plan may change, and we may need additional funds to meet operational needs and capital requirements for product development and commercialization sooner than planned.
Previous wording
Net cash used in operating activities was consistent year over year. While we experienced an increase in net loss of $9.4 million, this was wholly offset by changes in our operating assets and liabilities plus the receipt of accreted value associated with maturities on our short-term investment portfolio during the quarter.
Current wording
Net cash used in operating activities increased $20.5 million compared to the six months ended June 30, 2023, driven by an increase in net loss of $24.1 million, which was partially offset by the receipt of accreted value associated with maturities on our short-term investment portfolio during the six months ended June 30, 2024.
Previous wording
Net cash used in investing activities increased year over year was primarily due to purchase of marketable securities exceeding related maturities during the quarter.
Current wording
Cash Provided by (Used in) Investing Activities
Previous wording
Cash Used in (Provided by) Investing Activities
Current wording
Net cash provided by investing activities increased over the same period of prior year as maturities of marketable securities exceeded related purchases during the six months ended June 30, 2024, while purchases exceeded maturities during the six months ended June 30, 2023 as a result of the public offering of common stock in January 2023.
Previous wording
Net cash provided by financing activities decreased $251.5 million primarily due to net proceeds of $270.3 million from the Company's January 2023 underwritten public offering, which was partially offset by additional Term Loans entered into during the current quarter associated with the Amended Loan agreement.
Current wording
Net cash provided by financing activities decreased $251.0 million primarily due to net proceeds of $270.3 million from the Company's January 2023 underwritten public offering, which was partially offset by additional Term Loans entered into during the current six months ended June 30, 2024 associated with the Amended Loan agreement.
Previous wording
Except as mentioned below, there have been no material changes to our contractual obligations and other commitments as of March 31, 2024, as compared to those disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023.
Current wording
Except as mentioned below, there have been no material changes to our contractual obligations and other commitments as of June 30, 2024, as compared to those disclosed in the 2023 10-K.
Rearranged current paragraphs (6)
Current report — wording carried from elsewhere
Research and development expenses for the three months ended June 30, 2024 increased $12.6 million, primarily due to BEACON-IPF, a Phase 2b study of bexotegrast in patients with IPF, and related manufacturing activities.
Current report — wording carried from elsewhere
Interest and other income (expense), net increased $0.8 million, attributable to higher interest income due to increased yields on short-term investments.
Current report — wording carried from elsewhere
The decrease in revenue of $1.6 million is attributable to the termination of the Novartis Agreement that went into effect in April 2023.
Current report — wording carried from elsewhere
The following table summarizes our research and development expenses for the six months ended June 30, 2024 and 2023 (in thousands):
Current report — wording carried from elsewhere
We do not allocate our costs by product candidates or by preclinical programs as these are in early stages of clinical trials or development, and our internal expenses are not allocated between product candidates and programs. Although external third-party costs are allocable between product candidates and programs, we do not perform this allocation. We expect our research and development expenses to increase for the foreseeable future as we continue to invest in research and development activities related to developing our product candidates and our preclinical programs and as they advance into later stages of development.
Current report — wording carried from elsewhere
We expect our general and administrative expenses to increase for the foreseeable future as we continue to build our administrative function to support our growth in operations.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
•Muscular dystrophy program cleared for conduct of Phase 1 study. PLN-101325 is a monoclonal antibody designed to act as an allosteric agonist of integrin α7β1. The Company recently received regulatory clearance from Australia's Research Ethics Committee (HREC) for the conduct of a first-in-human Phase 1 clinical study of PLN-101325 which is being developed as a potential treatment for muscular dystrophies, including Duchenne muscular dystrophy (DMD).
Previous report — wording carried elsewhere
Interest and Other Income (Expense), net
Previous report — wording carried elsewhere
Interest and Other Income (Expense), net
Previous report — wording carried elsewhere
Comparison of the three months ended March 31, 2024 and 2023